510(k) K200862
K200862 is an FDA 510(k) premarket notification submitted by Sonavi Labs, Inc. for the device "Feelix Stethoscope". The FDA issued a decision of Substantially Equivalent on Sep 14, 2020. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 14, 2020
- Date Received
- Apr 1, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stethoscope, Electronic
- Device Class
- Class II
- Regulation Number
- 870.1875
- Review Panel
- CV
- Submission Type
- 510(k)